Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel

NCT ID: NCT01941615

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-01-31

Brief Summary

Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 207127 + faldaprevir + Microgynon

Period A: Microgynon®; Period B: Microgynon® + FDV + BI 207127

Group Type: EXPERIMENTAL

faldaprevir

Intervention Type: DRUG

oral doses for 10 days (period B)

Microgynon®

Intervention Type: DRUG

oral doses for 23 days (period A+B)

BI 207127

Intervention Type: DRUG

oral doses for 10 days (period B)

Interventions

faldaprevir

oral doses for 10 days (period B)

Intervention Type: DRUG

Microgynon®

oral doses for 23 days (period A+B)

Intervention Type: DRUG

BI 207127

oral doses for 10 days (period B)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy female subjects
• Age 18 to 35 years (inclusive)
• Body Mass Index 20-29.9 kg/m2
• Use of hormonal contraception (i.e. oral contraceptives, hormonal contraceptive vaginal ring, but not hormone-containing intrauterine devices, depot injections or contraceptive implants)

Exclusion Criteria

• Any relevant deviation from healthy conditions
• Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
• Positive pregnancy test, pregnancy or planning to become pregnant within 1 month of study completion, or lactation
• Any relevant finding of the gynaecological examination
• Thrombotic predisposition according to thrombophilic testing
• Existing or history of arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation
• Existing or history of confirmed venous thromboembolism, family history of venous thromboembolism, and other known risk factors for venous thromboembolism.
• Relevant varicosis
• No use of an additional contraceptive method from screening examination until 1 month after last study drug administration (acceptable methods are considered to be barrier methods, sexual abstinence, non-hormone-containing intrauterine device, or vasectomisation for the male partner).

Use of hormone-containing intrauterine device, depot injection or contraceptive implants

• Any history of relevant liver diseases (e.g. disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, or previous or existing liver tumours)
• AST (aspartate transaminase) and/or ALT (alanine transaminase) > 1.5 ULN (upper limit of normal)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1241.31.2 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Countries

Germany

Other Identifiers

2013-000298-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1241.31

Identifier Type: -

Identifier Source: org_study_id